Device recall
Z-0977-2017: NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product…
FDA device recall · Class I · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-0977-2017 |
|---|---|
| Recall event | 76026 |
| Product | NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG is intended to be used for the extraction of total nucleic acids from biological specimens. |
| Product code | PPM |
| Recalling firm | BioMerieux SA |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 10, 2022 |
| FEI number | 1000611339 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database